FDA.reportPublic FDA data

MAUDE MDR 6507449

MDR report key
6507449
Report number
MW5069207
Event key
0
Event type
3
Date of event
2017-04-12
Date received
2017-04-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COOK CERVICAL RIPENING BALLOON WITH STYLETCOOK CERVICAL RIPENING BALLOON WITH STYLETCOOK MEDICALHDYI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-1801. O

Event Narratives#

D

Patient 1

COOK CERVICAL RIPENING BALLOON WITH STYLET PIERCED THE END OF THE CATHETER DURING PLACEMENT AND COULD HAVE CUT THE BABY OR RUPTURED THE AMNIOTIC MEMBRANE, THE STYLET EXTENDED 1CM PAST THE END OF CATHETER TIP. ROUTE: VAGINAL. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER THE COUNTER: NO.